Metis Consulting Services has an excellent group of consultants who provide the biotech and pharmaceutical industries with strategic solutions that facilitate effective and innovative solutions in order to meet and exceed worldwide bench-to-market requirements from FDA and other regulatory agencies. Professional consultants in our company are passionate about ethics and the best interest of the patient. We provide quality, long-term solution options to our clients. There is no singular formulaic – each company’s needs are unique. And the right consultant to meet those needs is here at Metis.

Emily Barker (she/her) is a queer solo mom living in Carlsbad, CA. Most recently, she was at Cisco Systems for ten years, specializing in product and program management. She is an expert in big data and data visualizations. She is a practiced technical writer. She advocates for the customer in UX experience and design. Before her tech career, Emily held numerous roles in the biotech industry, including Invitrogen QAing eGels and Scripps Research Institute sequencing genes and proteins. She also spent time in academia working as a research assistant in reproductive genetics, drosophila genetics, and army ant behavior. She is set to graduate with her Master of Science in Cyberpsychology from Norfolk State University in June of 2024. Her diverse background also includes dual Bachelor’s degrees with emphases in Biochemistry and Latin American Literature from the University of San Diego. Emily grew up on a llama ranch in North County San Diego.

Area of Speciality: Regulatory

Cassandra David is a seasoned Pharmacovigilance (PV) professional with over 20 years of experience in global drug safety operations, specializing in PV process regulatory requirements and ICSR processing procedures. She graduated with a Bachelor of Arts from Boston University in 1996 and earned additional clinical research and health policy certifications. In May 2014, she obtained her nursing degree from Laboure College. Cassandra has held various positions in pharmacovigilance (PV) with expertise in adverse event monitoring and risk management. She loves to travel and enjoys experiencing different food and cultures in her leisure time. Booking an African safari is on her bucket list!

Area of Speciality: PV

Sam Lockhart is a cognitive neuroscience PhD who has studied late-life brain health for over 15 years. Dr. Lockhart’s career in neuroscience formed from a desire to understand how the brain produces function, cognition, and behavior. His specialization in brain aging and Alzheimer’s research is rooted in a desire to understand the brain in one of the most complex and important frameworks of our time: Can we promote the brain health span and protect people from disease? He is an Associate Professor in Internal Medicine – Gerontology and Geriatric Medicine at the Wake Forest School of Medicine. With all he does in bioscience, Dr. Lockhart enjoys being a Science Writer/Communicator the most. Sam’s family of six includes a dog and cat, and he says dog walking is his most reliable physical activity these busy days with two kids! Sam often picks up a guitar to relax and enjoys teaching his kids. His son is even learning how to jam! Sam also always tests out all new jokes with his wife, first.

Area of Speciality: Neuroscience

Rebecca Milliken is a GxP Quality professional with a particular interest in GLP activities. Rebecca’s foundation began in the laboratory where she worked on gene-editing technologies, becoming proficient in molecular techniques and cell culture. Wanting to learn about process improvement and project development, Rebecca obtained CAPM Certification from the Project Management Institute in 2022. Having worked at several small biotech start-ups, Rebecca believes strongly in the in the concept of building a robust quality management system that meets company needs at their current stage of development, but has the ability to grow with the company as it expands. Rebecca’s key activities include: management of the QMS (Quality Management System), eQMS implementation, vendor qualification, audits, policy and SOP authoring, and process improvement.
Rebecca holds a Bachelor of Science in Molecular Biology and Art History from the University of Wisconsin-Madison. In her free time, she enjoys riding her horses and cooking/baking.

Area of Speciality: GxP Quality

Carrie is a dedicated PV professional of 14+ years with a strong clinical background as an ER Nurse in trauma centers. Her expertise lies in developing and refining Pharmacovigilance Procedures. Give her Vendor Management, PSMF Generation and Maintenance, Inspection Prep & Activities, Literature Review, Risk Management, periodic safety reports (PSURs, DSURs, PADERs, etc.) to regulatory authorities, helping organizations with strict adherence to submission timelines and relevant guidelines (ICH E2D, E2F, etc.), And she is in her element.
Carrie has an unwavering commitment to drug safety which continues to drive her forward, seeking opportunities to make a meaningful impact in the industry.
When she’s not with her husband, 3 kids, and Golden Retriever, she enjoys running, reading, cooking & exploring!

Area of Speciality: PV & Operations

Dr. Christopher W. Stewart is currently owner and Principal Consultant for SGI Consulting, LLC. With over 30 years of experience in toxicology, he has acquired an extensive knowledge of Good Laboratory Practice (GLP) Regulations (including requirements by the FDA, EPA, OECD, and JMHLW) and recommendations by the International Conference for Harmonization (ICH). Dr Stewart primarily provides multidisciplinary advice to small pharmaceutical companies that lack their own staff toxicologist/pharmacologist. In many instances, the advice is associated with troubleshooting issues (from API production/formulation to project scheduling to addressing regulatory agency concerns to estimating a clinical safe starting dose) in an effort to keep a program moving forward.

Through the years, Dr Stewart has also acquired knowledge with small molecules and biologics as well as with numerous toxicology models and techniques [large animal pediatric and juvenile studies, small animal neurotoxicology studies, developmental toxicology studies, cardiovascular toxicology studies, dermal delivery studies, infusion delivery studies, efficacy model studies, nutritional studies, various small and large animal general toxicology studies, and carcinogenicity studies].

Over the course of Dr Stewart’s scientific career, he has managed, supervised and trained Study Directors, Study Coordinators, Scientific Staff, Technical Staff and Student Interns in the conduct of basic research and regulatory research. During this time, he has taken on and completed numerous projects by integrating the skill and qualities of various team members into a unified effort to accomplish a predetermined goal. As a result, Dr Stewart has come to understand that his greatest strengths are directly associated with his ability to enhance the competency level of others and facilitate their ability to get things done.

Area of  Speciality: Early Development, GLP, Toxicology

Professional Affiliations:
American College of Toxicology Full Member (2001-present).
Society of Toxicology Full Member (2000-present).

Steve is a highly accomplished professional in technology and quality, recognized as a thought leader in computer system validation (including CSA: computer software assurance) and paperless validation lifecycle management systems. He helps life science organizations realize the potential of artificial intelligence (AI, including machine learning and generative AI) and the qualification of IaaS, PaaS, and SaaS validation in cloud-computing environments, along with risk management strategies, remediation, and mitigation. He has conducted global audits for hundreds of organizations, including CROs, laboratories, and internal audits. He possesses in-depth knowledge of 21 CFR Part 11, Annex 11, PIC/S, FDA GxP predicate rules, and ISO 13485 and 14971 for medical devices. Steve’s experience spans regulatory bodies such as the FDA, EMA, Canada, Japan, Brazil, and Australia.

Steve has successfully built Quality Management Systems (QMS) for start-ups from scratch, including those in Decentralized Clinical Trial (DCT) technology, and has expertise in Agile iterative SDLC methodologies. He serves on the board of directors for the Society of Quality Assurance, Pacific Regional Chapter (PRCSQA). He is a published author and frequent speaker/lecturer at industry associations and universities. Steve enjoys spending time with his dog (Alexa) and cat (Siri), best friends and sisters. He also enjoys camping (especially off-grid), playing musical iinstruments, and all things artistic and creative.

Area of  Speciality: Technology and Quality

Meryl Wiernik is a Biopharma consultant with hands-on experience in developing processes and new departments, an expert in process optimization and change management and experienced in global harmonization, building/enhancing quality processes. She also has expertise in clinical trial management, vendor management, auditing, and building quality structure.

Area of  Speciality: Quality GCP